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FDA submission

The company is collecting validation evidence it intends to submit to the FDA next year, which will also support launch of  the test as an LDT.

It is the first of three ePlex molecular multiplex panels for the diagnosis and management of bloodstream infections that can lead to sepsis.

The company intends to use the funds to support submission of its NGS assay to the FDA, adoption of its testing by more health systems, and continued R&D.

The company said it will seek FDA approval for the assay, an expanded version of FoundationACT, as a CDx for targeted therapies and as a tumor mutation profiling assay.

The company has also developed two liquid biopsy cancer test, Liquid GPS Core for DNA and Liquid GPS Expression for RNA.

Company highlights during the first half of 2017 include China approval for Novaprep for non-gynecological cancer testing, and a €3 million private financing round. 

The firm's real-time PCR-based GeneStat system was developed leveraging IP licensed exclusively from the Translational Genomics Research Institute.

The test, which is currently for research use only, uses fluorescent multiplex PCR to co-amplify seven markers for analysis of the MSI-high phenotype.

Thermo Fisher developed the NGS-based multi-marker assay in collaboration with Novartis and Pfizer to match lung cancer patients with targeted drugs.

Despite lower than expected NGS instrument sales, Illumina expects continued growth in the oncology market as reimbursement increases. 

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The former commissioner of the FDA has returned to the venture capital firm New Enterprise Associates as a special partner on the healthcare investment team.

Astronauts have edited yeast genes on the International Space Station in an experiment designed to show how cells repair themselves in space.

Emory University has found that two of its researchers failed to divulge they had received funds from China, according to the Atlanta Journal-Constitution.

In Science this week: influence of the nuclear genome on human mitochondrial DNA, and more.